If a product has an expiration date exceeding 10 days, what is required for its use?

For a product that has an expiration date exceeding 10 days, the requirement for its use is to provide in-house testing data. This requirement exists to ensure the product's efficacy and safety for consumption beyond the initially assigned expiration date. In-house testing may include stability studies and other evaluations that confirm the product can be safely used without risking adverse effects or decreased therapeutic efficacy.

This requirement is essential in a pharmacy setting since it ensures that both pharmacists and patients can trust that the product remains effective and safe well past its listed expiration date. The necessity for testing data fundamentally supports pharmaceutical best practices and reinforces regulatory compliance.

While it might seem that a letter from the manufacturer or patient consent could be alternatives for ensuring product safety and efficacy, they do not meet the rigorous standards that in-house testing provides. Patient consent does not substitute for evidence of a product's potency and safety profile, and a manufacturer’s letter might not contain the specific data needed for a thorough evaluation of the product's stability beyond its expiration. Hence, having reliable, scientific in-house testing is paramount when using products that exceed the 10-day mark.